BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARCHITECT CORTISOL ASSAY

    Reg #: 1181121 · FEI: 1181121 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Fisher Diagnostics
    Registration Number
    1181121
    FEI Number
    1181121
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8365 VALLEY PIKE
    City
    MIDDLETOWN
    State
    VA
    ZIP
    22645
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062204

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Fluorometric, Cortisol JFT

    Proprietary Names

    ARCHITECT CORTISOL ASSAY Alinity i Cortisol Reagent Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility